Ana Rita Carvalho is a Senior Scientist and Technical Project Lead in Pilot Scale Downstream Purification within Lonza's Mammalian Development Services organization in Visp, Switzerland. She holds a degree in Biomedical Engineering and a M.S. in Clinical Engineering from the University of Minho, Portugal. In her current role, Rita leads technical activities supporting the transfer of downstream purification processes from development into GMP manufacturing. Her areas of expertise include process scale-up, technology transfer, troubleshooting, and operational readiness. She works closely with Process Development and Manufacturing Science & Technology (MSAT) teams to help bridge development and manufacturing, ensuring purification processes are scalable, robust, and operationally ready in support of customer programs.
Over the last decade, accelerated Gene-to-IND timelines have gone from being the exception to becoming an industry expectation. At the same time, biologics pipelines have become increasingly complex, with growing numbers of bispecifics, Fc-fusions and high-concentration molecules entering development.
While the drive to reach the clinic faster is strong, these next-generation biologics can introduce new challenges in areas such as expression, manufacturability, purification and formulation. In this presentation, we will discuss newly launched accelerated DNA-to-IND pathways for next-generation biologics and the scientific advances that are helping make these timelines possible.
Drawing on development experience, technical data and case studies, we will explore how innovation across early development can help accelerate progression to IND while maintaining confidence in product quality, manufacturability and future scalability.